We tested a new radiometric assay (Hépatube Wellcome) using a complete automatic device, in hepatitis B surface antigen detection with I 125 marked antibody. The additional advantage of this reagent is its very long life-span (twelve weeks after the date of manufacture). The hepatube system is fully automatic, micro processor-controlled and designed to complete all washing and tracer addition steps in the hepatube test sequence after addition of the patient's sample. The results were compared in the same protocol with those obtained by the method currently used in our group (Ausria II 125). This study has been carried out on 7.589 sera or plasma samples; blood donors 5.352; medical and chirurgical patients 1.292; sera panel 87; repeated tests 367; positives and negatives control sera 421; assays ran the first day 70 The 153 positive results (2.3%) were confirmed by another assay before neutralisation. The sensitivity of both techniques was compared using a reference panel containing samples showing varying degrees of positivity, and representative of both main subtypes. We repeated the assay on this panel 2 months after issue of materials and again 3 months later. This new system is more sensitive than Ausria II 125. Of 6 644 patients the false positive was found in 1,1% of the cases, this was superior to the results found with Ausria II 125 but there is no false negative with this new method. There was no difference when serum or plasma was used.

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http://dx.doi.org/10.1016/s0338-4535(84)80008-2DOI Listing

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